MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM— 510(k) K073625

Substantially Equivalent

Ge Healthcare Systems Information Technologies

FDA 510(k) clearance K073625 for MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM, Substantially Equivalent on 2008-01-25. Applicant: Ge Healthcare Systems Information Technologies.

Clearance details

Applicant: Ge Healthcare Systems Information Technologies
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2007-12-26
Decision date: 2008-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.